End Stage Renal FailureNCT04376567
Outcomes for One-stage and Two-stage Brachial Basilic Arteriovenous Fistulas
A study testing One stage approach in people with End Stage Renal Failure and Hemodialysis Access Failure, run by Tze-Woei Tan at 1 site in United States.
Trial summary
An arteriovenous (AV) fistula is essential for patients with kidney failure on dialysis. There is no clear data on the best method to create a new brachial basilic AV fistula (BBAVF), so the choice between a single procedure and two separate procedures is left to the surgeon. Both approaches are standard care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Failure, Hemodialysis Access Failure, Arterio-venous Fistula
- What is being tested?
- One stage approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2021to 1 Nov 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years;
- ESRD receiving hemodialysis in need for new hemodialysis access;
- Candidate for one-stage and two-stage BVT procedure as judged by the enrolling investigator;
- Greater than 3 mm diameter of upper arm basilic vein on venous duplex scan;
- Life expectancy ≥ 12 months;
Who cannot join
- Life expectancy < 12 months;
- Brachial artery stenosis or occlusion;
- A documented hypercoagulable state (defined as a known blood disorder associated with venous or arterial thrombosis);
- Current immunosuppressive medication, chemotherapy or radiation therapy;
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
United States1 site
Banner University Medical Center Tucson
Tucson, Arizona, 85724
About this study
Official title: Understanding the Patient-Centered Outcomes for One-stage and Two-stage Brachial Basilic Upper Extremity Arteriovenous Fistulas: A Pilot Trial
An arteriovenous (AV) fistula is essential for patients with kidney failure on dialysis. There is no clear data on the best method to create a new brachial basilic AV fistula (BBAVF), so the choice between a single procedure and two separate procedures is left to the surgeon. Both approaches are standard care. This study aims to compare patient-centered outcomes and quality of life by randomly assigning patients needing a BBAVF to either a one-stage or two-stage procedure.
Read the detailed description
The aim of the pilot trial is to compare the outcomes of patients with end stage kidney failure (ESKD) who are candidates for a new brachial basilic arteriovenous fistula (BBAVF). Patients will be randomized to either one-stage or two-stage BBAVF procedure, both standard of care for creating BBAVF. The main outcome will be primary clinical functional patency, defined as successful use of BBAVF over a continuous 4-week period without any need for additional procedure on the BBAVF. The secondary outcomes are fistula-related complications, duration of central venous catheter (CVC) for those on dialysis, and quality of life (QoL) measures. The study hypothesizes that the primary patency will be superior following the two-stage BBAVF procedure compare to one-stage procedure. However, CVC-related complications are expected to be higher following the two-stage procedure compared to the one-stage procedure. Patient will be followed for a minimum duration of 12-months per subject.
- Being tested
- One stage approach
- Keywords
- Renal failure, Upper extremity arteriovenous fistula, Brachial basilic arteriovenous fistula
- Medical subject headings
- Renal Insufficiency, Chronic, Arteriovenous Fistula, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One stage approachProcedure or surgery
Also called Two stage approach
Upper extremity brachial basilic arteriovenous fistula will be created either using one stage or two stage approach.
| Study group | Role | What they receive |
|---|---|---|
| One stage approach | Active comparator | To create a brachial-basilic arteriovenous fistula (BBAVF) using a one-stage approach. The arteriovenous anastomosis is performed and the basilic vein is transposed during the same procedure. Receives: Procedure: One stage approach |
| Two Stage approach | Active comparator | To create a BBAVF using a two-stage approach, the arteriovenous anastomosis is performed during the first procedure. The superficialization or transposition of the fistula is then performed 6 to 8 weeks later, after the fistula has matured. Receives: Procedure: One stage approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Had Successful Use of Arteriovenous Fistula for Dialysis
Functional clinical patency means the number of participants who were able to use their brachial basilic arteriovenous fistula (BBAVF) successfully for dialysis within 6 months of surgical creation. It refers to using two dialysis needles in at least 75% of dialysis sessions over four weeks without need for additional procedure or surgery, as determined by their providers.
Measured: 6 months
Secondary outcomes (3)
Number of Participants Who Had Catheter Related Complications
Number of participants with dialysis catheter related complications, including infection, procedure to exchange catheter due to malfunction.
outcomes of Primary Clinical Functional Patency or CVC-related bacteremia or death
Measured: 6 months
Number of Participants Who Had > 3 Months of Catheter Dependency After Arteriovenous Creation
Number of participants who had > 3 months of catheter dependency after arteriovenous fistula creation
Measured: 6 months
Patient-Reported Outcomes Measurement Information System Scores Over 6 Months
Average quality of life scores assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) for physical function, fatigue, sleep disturbance, and ability to participate in social roles and activities. Data are presented as T-score, which are standardized scores with a mean of 50 and a standard deviation for the reference population (typically the US general population). A T-score of 50 represents the population average. A higher T-score indicates more of the concept being measured and lower T-score indicate less.
Measured: 6-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2020
- Study start1 Oct 2021
- Primary completion1 Nov 2023
- Study completion1 Nov 2023
Why it stopped: The PI is leaving the institution and the trial will be not resuming.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for End Stage Renal FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Assigned to either a one-stage or two-stage approach for brachial-basilic arteriovenous fistula (BBAVF) creation in a 1:1 ratio.
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tze-Woei Tan
- Sponsor type
- University, hospital or other
- Collaborators
- University of Utah, Rancho Los Amigos National Rehabilitation Center
- Responsible party
- Sponsor-investigator, Tze-Woei Tan, University of Arizona
- Investigators
- Tze-Woei Tan, MD, Principal investigator, Banner University Medical Center Tucson/University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04376567
- Sponsor's protocol ID
- 0702
- Status last verified
- Sep 2025
- First submitted
- 15 Jan 2020
- Last updated
- 11 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Patient-Centered Outcomes for One-stage and Two-stage Brachial Basilic Upper Extremity Arteriovenous Fistulas: A Pilot Trial
- ClinicalTrials.gov ID
- NCT04376567
- Acronym / sponsor ID
- 0702
- Keywords
- Renal failure, Upper extremity arteriovenous fistula, Brachial basilic arteriovenous fistula
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The PI is leaving the institution and the trial will be not resuming.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Tze-Woei TanUniversity, hospital or other
- Collaborators
- University of Utah, Rancho Los Amigos National Rehabilitation Center
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 6 May 2020 (actual)
- Results
- Posted 11 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An arteriovenous (AV) fistula is essential for patients with kidney failure on dialysis. There is no clear data on the best method to create a new brachial basilic AV fistula (BBAVF), so the choice between a single procedure and two separate procedures is left to the surgeon. Both approaches are standard care. This study aims to compare patient-centered outcomes and quality of life by randomly assigning patients needing a BBAVF to either a one-stage or two-stage procedure.
Detailed description
The aim of the pilot trial is to compare the outcomes of patients with end stage kidney failure (ESKD) who are candidates for a new brachial basilic arteriovenous fistula (BBAVF). Patients will be randomized to either one-stage or two-stage BBAVF procedure, both standard of care for creating BBAVF. The main outcome will be primary clinical functional patency, defined as successful use of BBAVF over a continuous 4-week period without any need for additional procedure on the BBAVF. The secondary outcomes are fistula-related complications, duration of central venous catheter (CVC) for those on dialysis, and quality of life (QoL) measures. The study hypothesizes that the primary patency will be superior following the two-stage BBAVF procedure compare to one-stage procedure. However, CVC-related complications are expected to be higher following the two-stage procedure compared to the one-stage procedure. Patient will be followed for a minimum duration of 12-months per subject.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Assigned to either a one-stage or two-stage approach for brachial-basilic arteriovenous fistula (BBAVF) creation in a 1:1 ratio.
| Arm | Type | Receives |
|---|---|---|
| One stage approach | Active comparator | Procedure: One stage approachTo create a brachial-basilic arteriovenous fistula (BBAVF) using a one-stage approach. The arteriovenous anastomosis is performed and the basilic vein is transposed during the same procedure. |
| Two Stage approach | Active comparator | Procedure: One stage approachTo create a BBAVF using a two-stage approach, the arteriovenous anastomosis is performed during the first procedure. The superficialization or transposition of the fistula is then performed 6 to 8 weeks later, after the fistula has matured. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years;
- ESRD receiving hemodialysis in need for new hemodialysis access;
- Candidate for one-stage and two-stage BVT procedure as judged by the enrolling investigator;
- Greater than 3 mm diameter of upper arm basilic vein on venous duplex scan;
- Life expectancy ≥ 12 months;
Key exclusion criteria (5 listed)
- Life expectancy < 12 months;
- Brachial artery stenosis or occlusion;
- A documented hypercoagulable state (defined as a known blood disorder associated with venous or arterial thrombosis);
- Current immunosuppressive medication, chemotherapy or radiation therapy;
- Pregnancy or lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| One stage approachAlso: Two stage approachUpper extremity brachial basilic arteriovenous fistula will be created either using one stage or two stage approach. | Procedure or surgery | One stage approach, Two Stage approach |
Primary outcome
Number of Participants Who Had Successful Use of Arteriovenous Fistula for Dialysis
Time frame: 6 months
Functional clinical patency means the number of participants who were able to use their brachial basilic arteriovenous fistula (BBAVF) successfully for dialysis within 6 months of surgical creation. It refers to using two dialysis needles in at least 75% of dialysis sessions over four weeks without need for additional procedure or surgery, as determined by their providers.
3 secondary outcomes
Number of Participants Who Had Catheter Related Complications
Time frame: 6 months
Number of Participants Who Had > 3 Months of Catheter Dependency After Arteriovenous Creation
Time frame: 6 months
Patient-Reported Outcomes Measurement Information System Scores Over 6 Months
Time frame: 6-month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tze-Woei Tan, MD principal investigator
Banner University Medical Center Tucson/University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing One stage approach in people with End Stage Renal Failure and Hemodialysis Access Failure, run by Tze-Woei Tan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Had Successful Use of Arteriovenous Fistula for Dialysis (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025.